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The InterSpace GV Hip Spacer is indicated for temporary use (maximum 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin and vancomycin are the most appropriate antibiotics based on the susceptibility pattern of the infecting micro-organism(s).

The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The InterSpace GV Hip Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).

The InterSpace GV Hip Spacer is manufactured from PMMA with gentamicin and vancomycin and includes a stainless-steel core as well as a tapered wedge design. The InterSpace GV Hip Spacer is single-use, disposable, and provided sterile. The InterSpace GV Hip Spacer is inserted into the femoral medullary canal and acetabular cavity following the removal of the existing femoral and acetabular implants and debridement as part of a two-stage procedure due to a septic process. The device is protected from bacterial colonization due to the presence of gentamicin and vancomycin.

The provided text is a 510(k) clearance letter for a medical device called the "InterSpace GV Hip Spacer." This type of document is a regulatory approval and outlines the device's intended use, regulatory classification, and a summary of the reasons for its clearance (often by showing substantial equivalence to a predicate device).

However, this document does not contain the specific information required to answer your detailed questions about acceptance criteria and the study that proves the device meets those criteria, particularly regarding AI/algorithm performance and clinical validation.

The document states that "The information summarized in the Design Control Activities Summary demonstrates that the subject InterSpace GV Hip Spacer met the pre-determined acceptance criteria for the verification activities." It then lists the types of performance tests conducted (Mechanical Testing, Analysis of Antibiotic Content, Biocompatibility Assessment, Sterilization Validation, Shelf-Life Validation, Packaging Validation).

These tests are standard for a physical medical device (a hip spacer) to ensure its mechanical integrity, material compatibility, and sterile delivery, which are critical for its safety and function. They are not related to the performance of an AI/algorithm.

Therefore, I cannot populate the table or answer the specific questions related to AI/algorithm performance, ground truth establishment, sample sizes for AI training/testing, or MRMC studies, as the provided text does not describe a study involving an AI or algorithm.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document only generically states that "pre-determined acceptance criteria" were met for these categories. It does not provide the specific numerical or qualitative criteria themselves, nor the detailed results for each test.

2. Sample size used for the test set and the data provenance:

• Not applicable / Not provided. This document does not describe a study involving a "test set" in the context of an AI/algorithm. The "tests" mentioned are physical and chemical characterizations of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable / Not provided. No AI/algorithm study is described where ground truth would be established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable / Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC study was not done for this device. This is a physical hip spacer, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No, a standalone algorithm performance study was not done. This device is a physical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable / Not provided. The "ground truth" for this device's performance would be engineering specifications, material science standards, and in-vitro or in-vivo testing results to confirm physical and biological properties.

8. The sample size for the training set:

• Not applicable / Not provided. No AI/algorithm training set is mentioned.

9. How the ground truth for the training set was established:

• Not applicable / Not provided. No AI/algorithm training set is mentioned.

In summary: The provided FDA clearance letter pertains to a conventional medical device (a hip spacer) and its physical and material properties, not a software or AI-driven device. Therefore, the questions related to AI/algorithm performance and clinical validation through sophisticated study designs (like MRMC) are not relevant to this document.

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Bone Cement LV and HV are indicated for the fixation of joint prostheses to living bone in orthopedic musculoskeletal surgical procedures for rheumatoid arthritis, sickle cell anemia, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty.

Bone Cement Genta are intended for the fixation of prosthesis to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

The Bone Cement Genta are PMMA, radiopaque bone cements, containing gentamicin designed for the fixation of prosthesis to the living bone. The devices are a traditional bone cement product. The liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary blister with Tyvek lid, which is placed in an aluminum bag. The components are manually mixed immediately prior to use. The devices are sold disposable and sterile. The Bone Cement Genta are available in a low and high viscosity version.

The Bone Cement are PMMA, radiopaque bone cements designed for the fixation of prosthesis to the living bone. The devices are a traditional bone cement product. The liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary blister with Tyvek lid, which is placed in an aluminum bag. The components are manually mixed immediately prior to use. The devices are sold disposable and sterile. The Bone Cement are available in a low and high viscosity version.

The provided text is a 510(k) summary for polymethylmethacrylate (PMMA) bone cements. It details the device's characteristics, intended use, and comparison to predicate devices. However, this document does not contain the specific acceptance criteria or the study results in the format or level of detail requested for the device performance.

The section titled "PERFORMANCE DATA" (starting on page 9) lists the types of performance testing conducted but does not provide quantitative acceptance criteria or the reported device performance. It only states that the performance data demonstrate that the new devices are substantially equivalent to the predicate devices, and meet the requirements of the Special Controls Guidance Document.

Therefore, I cannot complete the table of acceptance criteria and reported device performance from the provided document. Similarly, details about sample sizes, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training set specifics for an AI/algorithm are not present as this document pertains to a bone cement, not an AI or imaging device.

If this were an AI/imaging device submission, the provided information would be insufficient to answer most of the requested points.

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The KYPHON™ VuE™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesing a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

KYPHON™ VuE™ Bone Cement is a polymethylmethacrylate (PMMA) acrylic resin intended for use for vertebroplasty or kyphoplasty procedures, and sacroplasty procedures. KYPHON™ VuE™ Bone Cement is a modification of the KYPHON® Xpede™ Bone Cement. Like the predicate, KYPHON™ VuE™ Bone Cement contains approximately 30% barium sulfate. However, KYPHON™ VuE™ Bone Cement contains barium sulfate in two forms (powder and granules) whereas the predicate has only the powder form of barium sulfate. The larger radio-opaque granules of barium sulfate increase visualization of the acrylic resin during delivery using fluoroscopy. KYPHON™ VuE™ Bone Cement is provided sterile in two components: 20 grams of powder and 9 grams of liquid. The powder contains methylmethacrylate-styrene copolymer, barium sulfate and benzoyl peroxide. The liquid contains methylmethacrylate (monomer), hydroquinone and N,N-dimethyl-p-toluidine. The components are manually mixed immediately prior to use.

This document is a marketing clearance (510(k)) for a medical device, KYPHON™ VuE™ Bone Cement, and as such, it primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than providing detailed acceptance criteria and performance data in the format typically seen for an AI/ML medical device.

Key takeaway: This document describes a PMMA bone cement, not an AI/ML device. Therefore, the specific types of acceptance criteria and study designs (e.g., MRMC studies, ground truth establishment with experts, data provenance for test/training sets) that are applicable to AI/ML devices are not relevant to this 510(k) submission and are not present in the provided text.

The document discusses acceptance criteria and performance data related to the physical and chemical properties of the bone cement, its biocompatibility, sterility, and shelf life, comparing it to existing predicate devices.

However, to answer your request using the information available and adapting it to the framework you provided (even though it's designed for AI/ML), I will interpret "acceptance criteria" and "device performance" in the context of this traditional medical device.

Acceptance Criteria and Device Performance for KYPHON™ VuE™ Bone Cement

The acceptance criteria for KYPHON™ VuE™ Bone Cement, as described in this 510(k) submission, are primarily based on demonstrating substantial equivalence to legally marketed predicate devices, particularly KYPHON® Xpede™ Bone Cement and Spineplex™ Bone Cement. This equivalence is established through various performance tests that ensure the new device meets established standards for bone cements.

1. Table of Acceptance Criteria and the Reported Device Performance (Adapted for a Non-AI/ML Device):

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